What is DermacinRx Lexitral PharmaPak?

Capsaicin is the active ingredient in chili peppers that makes them hot. Capsaicin is used in medicated creams and lotions to relieve muscle or joint pain.

Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that cause pain and inflammation.

DermacinRx Lexitral PharmaPak (for the skin) is a combination medicine used to treat joint pain, stiffness, and swelling caused by osteoarthritis of the knees. DermacinRx Lexitral PharmaPak may not be effective in treating arthritis pain elsewhere in the body.

DermacinRx Lexitral PharmaPak may also be used for purposes not listed in this medication guide.

Important Information

Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or use high doses, or if you have heart disease. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using diclofenac, especially in older adults.

Before taking this medicine

Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or use high doses, or if you have heart disease. Even people without heart disease or risk factors could have a stroke or heart attack while using DermacinRx Lexitral PharmaPak. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using diclofenac, especially in older adults.

You should not use this medicine if you are allergic to capsaicin or diclofenac, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure DermacinRx Lexitral PharmaPak is safe for you, tell your doctor if you have:

Using this medicine during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether capsaicin and diclofenac passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

This medicine is not approved for use by anyone younger than 18 years old.

How should I use DermacinRx Lexitral PharmaPak?

Follow all directions on your prescription label. Do not use this medicine in larger amounts or for longer than recommended.

Do not take by mouth. This medicine is for use only on the skin. If this medicine gets in your eyes, nose, or mouth, rinse with water.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

Do not apply to open wounds or to sunburned, chapped, irritated, or infected skin. Do not cover treated skin with a bandage or expose it to heat from a hot tub, heating pad, or sauna.

The usual dose of this medicine is 40 drops applied to each affected knee 4 times per day. Apply only 10 drops at a time, placing the medicine first into your hand and then onto your knee. Repeat until all 40 drops have been applied to each affected knee.

Apply the solution only to clean, dry skin. Spread the solution over the front, back, and sides of the knee.

Wash your hands after applying this medicine. Wait at least 30 minutes before you bathe or shower.

Wait until the solution is completely dry before covering treated skin with clothing or applying any other skin products (cosmetics, sunscreen, lotions, insect repellant, or other medicated skin products).

Do not allow others to touch the area where you have applied the medicine.

Capsaicin can cause a burning sensation wherever it is applied. This sensation is usually mild and should gradually lessen over time with continued regular use of the medicine.

If the burning sensation is painful or causes significant discomfort, wash the treated skin area with soap and cool water. Get medical attention right away if you have severe burning, pain, swelling, or blistering.

If you use this medicine long-term, you may need frequent medical tests.

Call your doctor if your arthritis symptoms do not improve after 7 days of treatment, or if your symptoms get better and then worse within a few days.

Store at room temperature away from moisture and heat.

DermacinRx Lexitral PharmaPak solution is flammable. Do not use near high heat or open flame. Do not smoke until the gel has completely dried on your skin.

What happens if I miss a dose?

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222, especially if anyone has accidentally swallowed it.

What should I avoid while using DermacinRx Lexitral PharmaPak?

Avoid exposing treated skin to heat, sunlight, or tanning beds.

Avoid taking a bath or shower within 30 minutes before or after you apply DermacinRx Lexitral PharmaPak to your skin. Also avoid vigorous exercise. Warm water or perspiration can increase the burning sensation caused by capsaicin.

Avoid getting this medicine in your eyes, nose, or mouth.

Avoid taking aspirin or other NSAIDs while you are using DermacinRx Lexitral PharmaPak.

Ask a doctor or pharmacist before using any cold, allergy, or pain medication. Many medicines available over the counter contain aspirin or other medicines similar to diclofenac. Using certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

DermacinRx Lexitral PharmaPak side effects

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

Although the risk of serious side effects is low when diclofenac is applied to the skin, this medicine can be absorbed through the skin, which may cause steroid side effects throughout the body.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath.

severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

skin rash, itching, redness, blistering, tingling, or other irritation where the medicine was applied; or

dryness or hardening of treated skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This list is not complete. Other drugs may interact with capsaicin and diclofenac, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.